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Amlodipine And Olmesartan Medoxomil is a brand name for Amlodipine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 1 INDICATIONS AND USAGE Amlodipine and olmesartan medoxomil tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial…
Verbatim from this product's FDA label. Tap a section to expand.
2 DOSAGE AND ADMINISTRATION The usual starting dose of amlodipine and olmesartan medoxomil tablets is 5/20 mg once daily. 1) ]. Recommended starting dose: 5/20 mg once daily ( 2 ). Titrate as needed in two-week intervals up to a maximum of 10/40 mg once daily ( 2 ).
1) . To report SUSPECTED ADVERSE REACTIONS, contact ScieGen Pharmaceuticals Inc. gov/medwatch. 1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
Amlodipine and olmesartan medoxomil tablets The data described below reflect exposure to amlodipine and olmesartan medoxomil tablets in more than 1600 patients including more than 1,000 exposed for at least 6 months and more than 700 exposed for 1 year.
1) ]. The population had a mean age of 54 years and included approximately 55% males. Seventy-one percent were Caucasian and 25% were Black. Patients received doses ranging from 5/20 mg to 10/40 mg orally once daily. The overall incidence of adverse reactions on therapy with amlodipine and olmesartan medoxomil tablets were similar to that seen with corresponding doses of the individual components of amlodipine and olmesartan medoxomil tablets, and to placebo.
8% for placebo). Edema Edema is a known, dose-dependent adverse effect of amlodipine but not of olmesartan medoxomil. The placebo-subtracted incidence of edema during the 8-week, randomized, double-blind treatment period was highest with amlodipine 10 mg monotherapy.
The incidence was significantly reduced when 20 mg or 40 mg of olmesartan medoxomil was added to the 10 mg amlodipine dose. 2% Across all treatment groups, the frequency of edema was generally higher in women than men, as has been observed in previous studies of amlodipine.
There was a greater decrease in hemoglobin and hematocrit in patients treated with amlodipine and olmesartan medoxomil tablets as compared to patients receiving either component. Adverse reactions seen at lower rates during the double-blind period also occurred in the patients treated with amlodipine and olmesartan medoxomil tablets at about the same or greater incidence as in patients receiving placebo.
5 WARNINGS AND PRECAUTIONS Anticipate hypotension in volume-or salt-depleted patients with treatment initiation. 2 ). 3 ). 4 ). Sprue-like enteropathy has been reported. 6 ). 1 Fetal Toxicity Amlodipine and olmesartan medoxomil tablets can cause fetal harm when administered to a pregnant woman.
Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations.
Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. 1) ] . 2 Hypotension in Volume- or Salt-Depleted Patients Olmesartan medoxomil. , those being treated with high doses of diuretics) symptomatic hypotension may be anticipated after initiation of treatment with olmesartan medoxomil.
Initiate treatment with amlodipine and olmesartan medoxomil tablets under close medical supervision. If hypotension does occur, place the patient in the supine position and, if necessary, give an intravenous infusion of normal saline.
A transient hypotensive response is not a contraindication to further treatment, which usually can be continued without difficulty once the blood pressure has stabilized. Amlodipine. Because of the gradual onset of action, acute hypotension is unlikely.
3 Increased Angina or Myocardial Infarction Patients, particularly those with severe obstructive coronary artery disease, may develop increased frequency, duration, or severity of angina or acute myocardial infarction on starting calcium channel blocker therapy or at the time of dosage increase.
The mechanism of this effect has not been elucidated. 4 Impaired Renal Function Changes in renal function may be anticipated in susceptible individuals treated with olmesartan medoxomil as a consequence of inhibiting the renin-angiotensin-aldosterone system.
2) ]. Do not co-administer aliskiren with amlodipine and olmesartan medoxomil tablets in patients with diabetes (4) .
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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These included hypotension, orthostatic hypotension, rash, pruritus, palpitation, urinary frequency, and nocturia. The adverse event profile obtained from 44 weeks of open-label combination therapy with amlodipine plus olmesartan medoxomil was similar to that observed during the 8-week, double-blind, placebo-controlled period.
Initial Therapy Analyzing the data described above specifically for initial therapy, it was observed that higher doses of amlodipine and olmesartan medoxomil tablets caused slightly more hypotension and orthostatic symptoms, but not at the recommended starting dose of amlodipine and olmesartan medoxomil tablets 5/20 mg.
No increase in the incidence of syncope or near syncope was observed. The incidences of discontinuation because of any treatment emergent adverse events in the double-blind phase are summarized in the table below. Discontinuation for any Treatment Emergent Adverse Event 1 1 Hypertension is counted as treatment failure and not as treatment emergent adverse event.
N=160-163 subjects per treatment group. 6% Amlodipine. S. and foreign clinical trials. Most adverse reactions reported during therapy with amlodipine were of mild or moderate severity. 5% of amlodipine-treated patients and about 1% of placebo-treated patients.
The most common side effects were headache and edema. 6 Olmesartan medoxomil. Olmesartan medoxomil has been evaluated for safety in more than 3825 patients/subjects, including more than 3275 patients treated for hypertension in controlled trials.
This experience included about 900 patients treated for at least 6 months and more than 525 treated for at least 1 year. Treatment with olmesartan medoxomil was well tolerated, with an incidence of adverse events similar to that seen with placebo.
Events were generally mild, transient, and without relationship to the dose of olmesartan medoxomil. The overall frequency of adverse events was not dose related. Analysis of gender, age, and race groups demonstrated no differences between olmesartan medoxomil- and placebo-treated patients.
, 32/1179) of control patients. In placebo-controlled trials, the only adverse event that occurred in more than 1% of patients treated with olmesartan medoxomil and at a higher incidence in olmesartan medoxomil treated patients vs. placebo was dizziness (3% vs 1%).
2 Post-Marketing Experience The following adverse reactions have been identified during post-approval use of the individual components of amlodipine and olmesartan medoxomil tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Amlodipine. The following post-marketing event has been reported infrequently where a causal relationship is uncertain: gynecomastia. In post-marketing experience, jaundice and hepatic enzyme elevations (mostly consistent with cholestasis or hepatitis), in some cases severe enough to require hospitalization, have been reported in association with use of amlodipine.
Postmarketing reporting has also revealed a possible association between extrapyramidal disorder and amlodipine. Olmesartan medoxomil. 6) ] Metabolic and Nutritional Disorders: hyperkalemia Musculoskeletal: rhabdomyolysis Urogenital System: acute renal failure, increased blood creatinine levels Skin and Appendages: alopecia, pruritus, urticaria Data from one controlled trial and an epidemiologic study have suggested that high-dose olmesartan may increase cardiovascular (CV) risk in diabetic patients, but the overall data are not conclusive.
The randomized, placebo-controlled, double-blind ROADMAP trial (Randomized Olmesartan And Diabetes MicroAlbuminuria Prevention trial, n=4447) examined the use of olmesartan, 40 mg daily, vs. placebo in patients with type 2 diabetes mellitus, normoalbuminuria, and at least one additional risk factor for CV disease.
The trial met its primary endpoint, delayed onset of microalbuminuria, but olmesartan had no beneficial effect on decline in glomerular filtration rate (GFR). There was a finding of increased CV mortality (adjudicated sudden cardiac death, fatal myocardial infarction, fatal stroke, revascularization death) in the olmesartan group compared to the placebo group (15 olmesartan vs.
18). The epidemiologic study included patients 65 years and older with overall exposure of > 300,000 patient-years. 8) compared to similar patients taking other angiotensin receptor blockers. 86) compared to similar patients taking other angiotensin receptor blockers.
No differences were observed between the groups receiving lower doses of olmesartan compared to other angiotensin blockers or those receiving therapy for < 6 months. Overall, these data raise a concern of a possible increased CV risk associated with the use of high-dose olmesartan in diabetic patients.
There are, however, concerns with the credibility of the finding of increased CV risk, notably the observation in the large epidemiologic study for a survival benefit in non-diabetics of a magnitude similar to the adverse finding in diabetics.
, patients with severe congestive heart failure), treatment with angiotensin converting enzyme inhibitors and angiotensin receptor antagonists has been associated with oliguria or progressive azotemia and (rarely) with acute renal failure and/or death.
3) ]. In studies of ACE inhibitors in patients with unilateral or bilateral renal artery stenosis, increases in serum creatinine or blood urea nitrogen (BUN) have been reported. There has been no long-term use of olmesartan medoxomil in patients with unilateral or bilateral renal artery stenosis, but similar effects would be expected with olmesartan medoxomil and amlodipine and olmesartan medoxomil tablets.
5 Patients with Hepatic Impairment Patients with hepatic impairment have decreased clearance of amlodipine. 5 mg in hepatically impaired patients is recommended. 6) ]. Since amlodipine is extensively metabolized by the liver and the plasma elimination half-life (t 1/2 ) is 56 hours in patients with severely impaired hepatic function, titrate slowly when administering to patients with severe hepatic impairment.
6 Sprue-like Enteropathy Severe, chronic diarrhea with substantial weight loss has been reported in patients taking olmesartan months to years after drug initiation. Intestinal biopsies of patients often demonstrated villous atrophy.
If a patient develops these symptoms during treatment with olmesartan, exclude other etiologies. Consider discontinuation of amlodipine and olmesartan medoxomil tablets in cases where no other etiology is identified. 7 Electrolyte Imbalances Amlodipine and olmesartan medoxomil tablets contain olmesartan, a drug that inhibits the renin-angiotensin system (RAS).
Monitor serum electrolytes periodically.